The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
Primary Purpose
Gastroesophageal Reflux Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Melatonin
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease
Eligibility Criteria
Inclusion Criteria:
- patient with GERD ranged from 42 to 56 years
Exclusion Criteria:
- patients with cardiac disease
- patients with renal affection
- patients with liver diseases (due to drug induced, autoimmune disease and viral hepatitis)
- patients on the drugs known to affect the GIT motility (phenothiazines, anticholinergics, nitrates or calcium channel blockers) were excluded during the time of conduction of the study or the preceding two weeks
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
No Intervention
Active Comparator
Arm Label
control
Group II
Group III, combined group
Group IV
Arm Description
9 healthy normal subjects.
Included 9 patients suffering from GERD; receiving melatonin alone for treatment of GERD in a dose of 3 mg once daily at the bed time.
Included 9 patients suffering from GERD; receiving omeprazole alone for treatment of GERD in a dose of 20 mg twice daily.
Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00915616
Brief Title
The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
Official Title
The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
5. Study Description
Brief Summary
Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Many drugs used for the treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury. Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused by reactive oxygen species in different experimental ulcer models. The aim of this study is to evaluate the role of exogenous melatonin in the treatment of reflux disease in human either alone and in combination with omeprazole therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
9 healthy normal subjects.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Included 9 patients suffering from GERD; receiving melatonin alone for treatment of GERD in a dose of 3 mg once daily at the bed time.
Arm Title
Group III, combined group
Arm Type
No Intervention
Arm Description
Included 9 patients suffering from GERD; receiving omeprazole alone for treatment of GERD in a dose of 20 mg twice daily.
Arm Title
Group IV
Arm Type
Active Comparator
Arm Description
Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them.
Intervention Type
Drug
Intervention Name(s)
Melatonin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patient with GERD ranged from 42 to 56 years
Exclusion Criteria:
patients with cardiac disease
patients with renal affection
patients with liver diseases (due to drug induced, autoimmune disease and viral hepatitis)
patients on the drugs known to affect the GIT motility (phenothiazines, anticholinergics, nitrates or calcium channel blockers) were excluded during the time of conduction of the study or the preceding two weeks
12. IPD Sharing Statement
Citations:
PubMed Identifier
20082715
Citation
Kandil TS, Mousa AA, El-Gendy AA, Abbas AM. The potential therapeutic effect of melatonin in Gastro-Esophageal Reflux Disease. BMC Gastroenterol. 2010 Jan 18;10:7. doi: 10.1186/1471-230X-10-7.
Results Reference
derived
Learn more about this trial
The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
We'll reach out to this number within 24 hrs